We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Clears New Indications for Lyme Disease Diagnostics

FDA Clears New Indications for Lyme Disease Diagnostics

FDA_Logo_Black_2016.gif
July 30, 2019

The FDA has OK’d four diagnostic tests with new indications for diagnosing Lyme disease.

“The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially” rather than the current two-step Western Blot test, the agency said.

The new assays are easier to interpret in the laboratory due to the streamlined methods for running the tests, CDRH said.

View today's stories

Medical Devices Submissions and Approvals

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 13Sep

    Trial Master File Inspection Readiness: From Chaos to Calm

  • 14Sep

    Omnichannel Engagement: Are You Digitally Ready?

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Guardant Health Receives FDA Approval for Guardant360 CDx Liquid Biopsy Test

  • Genentech Inks Licensing Deal With Jemincare Over Androgen Receptor Degrader

  • FDA Clears Thermo Fisher Scientific’s Wheat and Sesame Allergy Tests

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing